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The proposed assessment elements are intended to promote convergence of regulatory approaches, enhance technical capabilities of regulators and stakeholders and generate faster evidence. Read More
FDA officials welcomed a risk-based approach to CAPA systems during a session at 2017 RAPS Regulatory Convergence, but cautioned that each CAPA investigation is unique. Read More
Brazil’s National Agency for Sanitary Surveillance is streamlining its process for good manufacturing practice certification to allow faster access to new technologies. Read More
The FDA issued warning letters to five device manufacturers for a range of issues, including a failure to seek pre-market approval, to apply for modified intended uses, and quality violations. Read More